Device product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Z-1813-2013
Product summary
- Firm
- HeartWare Inc
- Event
- Event 65328
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76 (US) and 82 (International)
- Official record key
device-enforcement:Z-1813-2013
Official wording
Reason: Potential to electrostatic discharged (ESD)
Code information: US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
Distribution pattern: Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Derived failure modes
-
Unknown
Potential to electrostatic discharged (ESD)